SUPPLY CHAIN ARTICLES
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Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why
The demand for plasmid DNA products is intrinsically linked to unique market conditions and funding environments. Here's what's driving them.
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The mRNA Supply Chain Revolution: Materials, Methods, And Momentum
mRNA innovation now hinges as much on manufacturing materials as on molecular design, with novel inputs shaping performance, cost, and scalability. As these less-mature materials move rapidly into production, strategic material selection and supplier alignment are becoming critical to manufacturing resilience and long-term success.
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4 Risk Mitigation Strategies For mRNA Production
Planning and procuring custom materials needed to manufacture mRNA remains a top concern. This article shares risk mitigation strategies for multi-sourcing, S&OP process, packaging size, and material expiry.
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FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities
The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.
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Addressing Challenges In Serialization For Complex Therapeutics
The magnitude of serialization, especially for firms with extensive portfolios and intricate supply chains, poses serious challenges. This discussion offers solutions.
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Moderna & The Global mRNA Supply Chain: Regulatory Lessons Learned
One of the most important reminders I took away from Moderna’s experiences ushering its mRNA vaccine onto the global market is that a commercial manufacturing process must also be accompanied by a commercially ready supply chain. Though sufficient physical volumes of each raw material and a redundant supplier network are necessities, physical scale is not the only “CQA” for which we must account when commercializing our supply chain.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Explore the stocking solution offered to a mid-sized CDMO in need of a high volume of safety stock inventory to support their customer portfolio growth.
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Researchers demonstrate a delivery mechanism that is a simple and ready-to-use transfection reagent that leads to outstanding transfection efficiencies in known hard-to-transfect stem cells.
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Cryopreservation should be integrated across the entire supply chain to ensure traceability, reduce risk at handoffs, and support consistent, scalable therapy development and delivery.
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Learn how to approach CRISPR cell and gene therapy development challenges, such as regulatory hurdles, ensuring consistency, finding qualified and experienced staff, and obtaining GMP-Grade reagents.
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Rapid advancements in mRNA-based therapeutic development have underscored the role of raw material quality and supply chain management in ensuring their successful production.
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Drive the efficiency and resiliency of supply chains by integrating automation, AI, and effective communication, ensuring the successful distribution of lifesaving medicinal products.
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Ensuring consistent replication and proper retention of plasmid DNA sequence is vital to the economics and efficiency in generating starting materials used for production of AAV delivered gene therapy and mRNA vaccines and therapeutics.